Clinical Trial: Amyloid Beta and Cognition in Parkinson Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: The Role of Amyloid Beta in the Progression of Cognitive Impairment in PD: A Prospective Cohort Study

Brief Summary: The investigators propose to study persons with Parkinson Disease (PD) with detailed clinical, cognitive and imaging at the time of study entry and repeat these assessments 2 years later. The study looks at how changes in activity of the neurotransmitter acetylcholine relates to changes in cognitive function and to see if there is presence or build up of amyloid protein.

Detailed Summary: Participants with PD will be studied at initial visit assessing clinical, cognitive, and brain imaging. A one year and, if applicable, three year cognitive assessment will be done, and the entire/complete assessment (same as initial visit) will be repeated again at two years. There will be a maximum of three follow up visits. The imaging test battery will consist of amyloid and acetylcholine brain PET and MRI scans. The use of acetylcholine PET imaging will demonstrate how changes in activity of this neurotransmitter relate to changes in cognitive functions, such as memory and mental concentration. A key question will be whether persons with PD who not only are losing acetylcholine brain cells but also have the buildup of the Alzheimer amyloid protein have a more rapid progression with more severe cognitive decline and behavioral changes compared to persons who do not have the amyloid protein.
Sponsor: University of Michigan

Current Primary Outcome:

  • Cholinergic innervation [ Time Frame: Change from Baseline in cholinergic innervation at 2 years ]
    FEOBV PET scan
  • Cortical Amyloid Beta plaques [ Time Frame: Change from Baseline in beta-amyloid deposition at 2 years ]
    PIB PET scan
  • Cognitive function [ Time Frame: Change from Baseline in cognitive function at 2 years ]
    Detailed neuropsychological test battery


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Michigan

Dates:
Date Received: December 13, 2012
Date Started: February 2013
Date Completion: February 2018
Last Updated: May 2, 2017
Last Verified: May 2017